Suppliers and packagers for dostinex

dostinex

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	DOSTINEX	cabergoline	TABLET;ORAL	020664	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-1005-1	8 TABLET in 1 BOTTLE (59762-1005-1)	2014-09-22

Dostinex (cabergoline) Suppliers: Who Manufactures Dostinex Tablets and APIs, and What the Supply Chain Looks Like

Last updated: June 2, 2026

Dostinex is cabergoline, an ergot-derived dopamine agonist. The commercial product is marketed under the name Dostinex, while the underlying active ingredient is cabergoline. Supplier mapping depends on whether you mean (1) branded finished-dose manufacturers, (2) API suppliers, or (3) toll/manufacturing partners used by marketing authorization holders across geographies. This overview consolidates the key supplier groups and the most common upstream manufacturing model used for cabergoline.

Who supplies Dostinex (cabergoline) tablets by manufacturer and finished-dose site?

Answer: Dostinex tablets are typically supplied by the marketing authorization holder (MAH) and filled/finished at contracted manufacturing sites, with local distribution handled by country-specific distributors. The MAH’s finished-dose supply chain usually includes one or more contract manufacturing organizations (CMOs) for tablet manufacturing and packaging, then import or distribution into each market.

Who is the marketing authorization holder for Dostinex?

In practice, the MAH for Dostinex differs by country license. For a sourcing plan, the MAH listed on the local product label and the manufacturer listed as “manufactured by” in local regulatory files is the operational supplier target.

What manufacturing steps define “supplier” for Dostinex?

For tablet supply, the operational supplier may control one or more of:

• Tablet compression and finishing (including blending, granulation where applicable, compression, drying if needed)
• Film coating and tablet imprinting
• Packaging (blister, bottle, unit dose)
• Release testing under GMP

What companies supply cabergoline API used to make Dostinex?

Answer: Cabergoline API supply is concentrated in established generic and specialty API manufacturers, often with multiple qualified sources. API availability is also shaped by whether the supplier can support DMF-backed regulatory filings in the target jurisdiction.

What to look for in API sourcing (cabergoline)

When mapping cabergoline API suppliers, the most decision-relevant artifacts are:

• DMF holders and associated US FDA file status (if applicable)
• European Drug Master File (if marketed through EMA routes)
• GMP inspection status for API manufacturing sites
• Ability to meet specification for polymorph/particle size and impurity profile

How cabergoline API is typically procured in pharma supply chains

Most branded and generic formulators procure cabergoline from:

• Dedicated API manufacturers with DMF or EU dossier support
• Long-term qualified supplier lists maintained by the MAH
• Secondary sourcing for business continuity (capacity and risk coverage)

Which upstream suppliers are most relevant for global cabergoline supply continuity?

Answer: The suppliers that matter for global continuity are those with:

• Multi-site manufacturing footprint (primary and backup API sites)
• Demonstrated ability to supply multiple registrants
• History of regulatory-file support (DMF, CEP/DMF-like documentation)
• Proven ability to deliver under forecast and short-notice demand

Because cabergoline is a niche but long-established drug, the API market often shows “few qualified suppliers” dynamics. This makes supply continuity heavily dependent on maintaining at least two qualified sources for the API and at least two qualified fill-finish sites for finished tablets.

Are there multiple brands or parallel imports for cabergoline like Dostinex?

Answer: Yes. Cabergoline tablets are sold under other brand names in many countries, and those products often share the same API supplier pool. Parallel imports can also shift the actual physical source of tablets, even if the label brand remains “Dostinex.”

How to identify the actual tablet supplier in a given country

Use:

• Product label “manufactured by” and “packaged by” fields
• National drug register listing for product and manufacturer
• Batch release data where available

What does a practical supplier due-diligence checklist look like for Dostinex supply?

Answer: For procurement and regulatory submission readiness, the due-diligence focus should be:

• Confirm API and finished-dose GMP compliance for the specific sites
• Verify quality agreement terms (specifications, OOS/OOT handling, deviation reporting)
• Confirm regulatory dossier linkage (DMF/CEP) where required
• Verify cold-chain needs (cabergoline tablets typically do not require special storage beyond standard conditions, but packaging and distribution terms still matter)
• Confirm supply capacity for the contract period and surge orders

What supply risks exist for cabergoline (Dostinex) procurement?

Answer: The key risks for cabergoline supply are:

• API capacity constraints due to a small number of qualified suppliers
• Batch-to-batch impurity profile drift risk if suppliers change processes or sources
• Regulatory documentation delays if dossier support is not pre-established
• Finished-dose packaging line constraints (blister/bottle availability and packaging film or printing material)

How do generic entrants affect Dostinex supplier leverage?

Answer: In many markets, generic cabergoline tablets compete on price. This can push API buyers into tighter allocation during shortfalls and can increase bargaining power of the API supplier pool. Finished-dose CMOs can also prioritize higher-volume or higher-margin contracts during constrained periods.

What “supplier leverage” means operationally

• API lead times can extend during allocation events
• Minimum order quantities can rise when suppliers operate near capacity
• Alternate sources may require requalification and regulatory amendments

Key Takeaways

• Dostinex is cabergoline tablets; supplier mapping must distinguish MAH-finished-dose manufacturer versus upstream cabergoline API suppliers.
• Cabergoline API is typically sourced from a small set of qualified GMP suppliers with dossier support (DMF/EU filings), and supply continuity depends on maintaining multi-source qualification.
• Finished-dose supply is usually handled via contract manufacturers for tablet production and packaging, with country-specific labeling revealing the actual “manufactured by” site.
• Procurement risk centers on API capacity concentration and packaging-line constraints, not on the molecule itself.

FAQs

1) Who actually manufactures Dostinex tablets in the US and EU?
The “manufactured by” site is determined by the local regulatory listing for the specific product presentation. Supplier identification should come from the official product label and national register entry.

2) Which API supplier(s) provide cabergoline for branded and generic cabergoline tablets?
Cabergoline API is supplied by qualified GMP API manufacturers supporting dossier submissions. The most reliable mapping uses DMF/EU file holders tied to commercial registrants and confirmed GMP sites.

3) How do I find the batch manufacturer of Dostinex for a specific lot?
Use the carton and blister/bottle labeling for that lot to identify the “manufactured by” and batch/lot details, then map that site to the regulatory listing.

4) What documentation is typically needed to qualify a cabergoline API supplier?
Quality agreement, CoA/CoC history, GMP certificates for API site, impurity and specification confirmation, and regulatory dossier linkage (DMF/CEP-like evidence where required).

5) Does cabergoline tablet supply require special storage conditions?
Most cabergoline tablet presentations follow standard controlled room temperature storage without cold-chain requirements, but exact labeled conditions control procurement and distribution planning.

References

1. (No external sources provided in the prompt.)